Three-born Jian HER2 single resistance was approved, breast cancer market ushered in a new change.

On June 19, 2020, initomab, independently developed by Sansheng Guojian, was approved by nmpa, with the trade name of cypriotine? For the treatment of HER2 positive metastatic breast cancer.this product is the first self-developed HER2 monoclonal antibody in China. It is also the National 863 plan, the national major new drug creation project and the key scientific and technological research project in Shanghai. It is also a priority review variety.bring more choices for Chinese patients with HER2 positive metastatic breast cancer.according to the latest data, the annual incidence of breast cancer in China is 3.92 million, accounting for 2 / 3 of the urban population. The incidence rate of breast cancer inranked the fifth in all malignant tumors in China, ranked first in women, accounting for 17% of all female malignant tumors.at present, the main anti HER2 mAbs in China are trostuzumab of Roche (Herceptin?) and patuzumab (pajite?).in January 2020, the Roche antibody coupled drug emmettrazumab (herculex?) was also approved for marketing in China.the approval of Sansheng Guojian yinitumab is undoubtedly the first to break the monopoly pattern of foreign pharmaceutical enterprises in this field.Roche's trastuzumab ranks first in the global breast cancer drug treatment field, and leads the whole market.in 2019, trastuzumab was the product of Roche HER2, with sales of 6.039 billion US dollars, a decrease of 13.5% compared with the same period of the same period; the sales of patuzumab were 3.522 billion US dollars, an increase of 27.0% over the same period; and the sales of emmettrazumab were 1.393 billion US dollars, an increase of 42.3% over the same period.in the field of HER2 positive breast cancer, Roche has launched the second generation of monoclonal antibody patuzumab. Since pajite was approved for marketing, Herceptin combined with pajite combined with chemotherapy for HER2 positive breast cancer is a perfect match.in this field, Roche welcomed the approval of nmetrazumab in 2013, which is the first antibody coupled drug approved for breast cancer in the world. The drug currently covers the second-line treatment of advanced / metastatic breast cancer and the adjuvant treatment of HER2 positive early breast cancer patients with residual invasive lesions after the new adjuvant therapy for HER2 positive early breast cancer.Figure 1: market sales of Roche HER2 monoclonal antibody (unit: million US dollars) in the past two years, in addition to trastuzumab, the market of patuzumab and emmettrazumab showed a high growth trend. As the follow-up products of Roche HER2 monoclonal antibody market, patuzumab and nmetrastuzumab have added strong impetus to the company.Table 2: approval of three major Roche HER2 products FDA and nmpa. Up to now, with the approval of Roche entetrastuzumab in China, all the three major products of Roche HER2 positive breast cancer have entered China, and Roche has made a comprehensive layout in the field of HER2 positive breast cancer.according to the statistics of domestic sample hospitals, the sales volume of trastuzumab was 410 million yuan in 2012, 500 million yuan in 2013, 1 billion yuan in 2018, and 1.945 billion yuan in 2019, an increase of 48.4% over the same period. Affected by the medical insurance policy, the growth rate of trastuzumab in the past two years has been significantly accelerated.Figure 2: Sales of Roche Herceptin in domestic sample hospitals from 2012 to 2019 (unit: 10000 yuan). Due to the demand for HER2 breast cancer and other indications, HER2 breast cancer market has great potential.according to the CSCO breast cancer diagnosis and treatment guidelines of 2019 edition, trastuzumab has already become the most basic treatment option, while patuzumab has approved three indications within a short period of one year, and has been included in the guideline immediately. However, emmettrazumab has been recommended as grade 1a, which shows the expectation of breast cancer experts in China. on November 28, 2019, trastuzumab was successfully renewed through the negotiation of national health insurance, and new indications for neoadjuvant therapy were added; and the neoadjuvant therapy of patuzumab for HER2 positive patients with locally advanced, inflammatory or early breast cancer and for patients with high risk of recurrence of HER2 positive early breast cancer were also included in the national health insurance for the first time (2019 Edition). Br / > after less than one year, patients with breast cancer were successfully included in the national health insurance list. sanshengguojiansaiputin has broken the HER2 antibody monopoly pattern. According to the report released by the National Cancer Center in 2019, the number of new breast cancer patients in China in 2015 was 304 000, among which 20% - 25% of breast cancer patients were HER2 positive patients. The clinical practice of HER2 positive breast cancer still has a huge demand for treatment. since the world's first HER2 targeted monoclonal antibody was approved for marketing in the United States in 1998, anti HER2 drugs combined with chemotherapy drugs and other drugs have been widely used in clinical treatment. in addition, HER2 targeted drugs continue to expand indications in the field of colorectal cancer, lung cancer, cholangiocarcinoma, pancreatic cancer and other diseases. There is still a large market growth space for anti HER2 drugs including anti HER2 monoclonal antibody and anti HER2 small molecule compounds in China. the approval of initomab for injection broke the monopoly pattern of imported HER2 antibody. up to now, 23 new HER2 antibody drugs have been declared in China, and the competition is extremely fierce. in addition to Sansheng Guojian, the biological analogues of Fuhong Hanlin trastuzumab are under review and approval. conclusion in recent years, China's drug regulatory authorities have continuously improved the efficiency of review and approval, enhanced the national health insurance negotiations, and effectively solved the problem of accessibility and affordability of the people to use high-quality innovative drugs. as an innovative biomedical enterprise focusing on antibody drugs in China, Sansheng Guojian Pharmaceutical Co., Ltd. has a multi-target layout. At present, it has a variety of leading antibody products in different development stages, and cyproterin is the first Chinese innovative biological drug approved for anti HER2 target. the approval of cypriotine is another solid foundation for Sansheng pharmaceutical in the innovation of antibody drugs, and will also bring hope for survival for more patients. is smegmaglutide really more affordable for diabetes? Esomeprazole global more than 60 billion US dollars, domestic enterprises compete, immediately unlock your palm professional tools!